Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.
- Company
- Volcano Corporation
- Recall Initiated
- August 13, 2014
- Posted
- September 12, 2014
- Terminated
- June 30, 2015
- Recall Number
- Z-2636-2014
- Quantity
- 8251 total devices (3777 US)
- Firm Location
- Rancho Cordova, CA
Reason for Recall
Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.
Lot / Code Info
Part number 91003: All Lots
Root Cause
Packaging
Action Taken
Volcano sent an Urgent Product Recall Notification letter dated August 13, 2014, to all customers who received the device in the last 25 months. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use of the affected product and return unused devices to the Volcano distribution center. Customers were asked to prepare the attached inventory log and then contact Volcano Customer Service at 800-228-4728, option 4 to arrange for return of any affected product in their inventory. A credit would be issued for any returned product. Customers with questions were asked to call 800-228-4728. For questions regarding this recall call 978-439-3586.